Parul
In a landmark decision that prioritises patient safety and fosters domestic innovation, India’s drug regulatory authority has directed the Customs Department to halt the import of refurbished medical devices until a comprehensive policy framework is in place. The PHD Chamber of Commerce and Industry (PHDCCI) has welcomed this decision, calling it a critical step to fortify India’s medical device industry under the ‘Make in India’ initiative.
The directive addresses growing concerns over unregulated imports of refurbished medical equipment that lack proper certification, potentially jeopardising patient safety. The regulator highlighted that the Medical Devices Rules, 2017, do not provide provisions for licensing such imports, rendering their sale and distribution in India unlawful.
Gaurav Aggarwal, Co-Chair of the Medical Device Committee at PHDCCI and Managing Director of Innvolution Healthcare, welcomes and applauds the clarity provided by the Central Drugs Standard Control Organisation (CDSCO) regarding the prohibition of importing refurbished medical devices under the Medical Devices Rules (MDR) 2017 for sale and distribution in India.
This decisive clarification reinforces the regulatory framework designed to ensure the highest standards of patient safety while creating a robust environment for the growth of indigenous manufacturing. By eliminating ambiguity, CDSCO has further strengthened the push towards self-reliance, innovation, and quality in India’s medical technology sector, perfectly aligning with the ‘Make in India’ and ‘Atmanirbhar Bharat’ initiatives.
PHDCCI has consistently championed the need for stringent regulatory oversight in the medical device sector. The Chamber has proactively engaged with policymakers, highlighting the risks posed by uncertified refurbished equipment and advocating for measures that align with global standards.
As the Ministry of Health and Family Welfare initiates the process to establish a robust policy framework, PHDCCI remains committed to supporting this initiative to ensure patient safety, regulatory clarity, and industry growth. The Chamber emphasises the urgency of creating a balanced approach that safeguards underserved regions while empowering domestic manufacturers to meet rising demands across the country.
